The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Job Title: Senior Director, Regulatory Affairs & Safety Reports To: VP, Regulatory & Business Operations
The Senior Director, Regulatory Affairs and Safety will provide regulatory leadership as well as support development of strategies to facilitate communications with regulatory authorities, submissions and maintenance of investigational and approved drug applications, and related pharmacovigilance activities.
Job Responsibilities & Performance Standards:
Serves as internal subject matter expert and as a resource to provide senior technical expertise in relation to guidance on regulatory affairs and pharmacovigilance issues/strategies for pharmaceutical products;
Acts as an assigned point of contact and liaison with appropriate FDA officials and worldwide regulatory agencies and vendors supporting regulatory affairs and pharmacovigilance activities;
Provides the organization with both short and long term strategies in order to support business objectives and product development/support in the regulatory affairs area;
Plans budget and resource requirements to conduct cost-effective regulatory affairs and pharmacovigilance programs that yield necessary information to allow for efficient business decisions;
Maintains a working knowledge of the preparation of regulatory submissions in support of IND, NDA, BLA, and ANDA activities, as applicable;
Assigns tasks and supervises the work of assigned direct reports;
Oversees/creates/reviews regulatory activities associated with assigned regulatory applications (e.g. IND, NDA) including planned submissions and annual reporting requirements;
Reviews regulatory submissions for consistency and accuracy, recommends changes, and obtains appropriate approvals prior to submission;
Documents regulatory authority and pharmacovigilance communications and keep management advised when issues emerge;
Assists in local (i.e. KPA) and global (i.e. KCL) SOP development and review;
Supports the department in the preparation, coordination, and management of regulatory agency inspections, internal quality assurance audits, and in-licensing/out-licensing due diligence activities;
Demonstrates leadership skills: coaches/mentors/supports peers and direct reports;
Keeps up to date with current regulatory guidelines and regulations;
Abides by company policies regarding safety rules and regulations;
Adapts to various situations and adjusts to shifting priorities;
Performs other duties as assigned.
Experience and Skills:
A Bachelor of Science degree in the pharmaceutical or biological sciences (or related field) is required; an advanced or professional degree is strongly preferred.
Minimum 10 years (Ph.D.), 14 years (M.S.) or 20 years (B.S.) of relevant experience is required, preferably within the pharmaceutical or biotechnology industry.
At least 5 years of direct management experience preferred.
Experience in preparing US and non-US regulatory dossiers, including electronic submissions required.
Technical expertise in US and foreign regulatory requirements, guidelines and processes specifically related to pharmaceutical development, manufacturing, distribution, regulatory approval, and pharmacovigilance.
Ability to review documents and technical activities precisely with an attention to detail is essential.
Ability to work and coordinate activities with and across various organizations as well as organizational functions and levels is essential.
Maintains comprehensive proficiencies with Adobe Acrobat and Microsoft Office and associated modules.
Excellent oral and written communications skills, excellent problem solving abilities, accurate data entry, and exceptional organizational skills required.
Capable of working in a team-oriented and rapidly changing environment.
Travel (including international travel from time to time) to visit partners and attend relevant conferences or meetings is a critical part of the job, so the candidate must be willing to travel up to 30% of the time. Flexibility in scheduling travel also required.
NOTE: The information presented, while not an exact or exhaustive listing, describes the work, performance standards, and qualifications typically required of positions of employees in this job. A specific position description or employee performance plan may differ as long as it is consistent with the core Responsibilities, Standards and Qualifications for that job.
Kowa is committed to provide equal opportunity, employment, and advancement opportunities to all individuals. Kowa does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, protected veteran, pregnancy, status as a qualified individual with a disability, or any other characteristic protected by Federal, State, or Local Laws. Employment decisions at Kowa will be based on merit, qualifications, and abilities.
Internal Number: 1953
About Kowa Pharmaceuticals America, Inc.
A legacy of trust. A future of care. Established in 2008, Kowa Pharmaceuticals, Inc., is committed to developing and delivering safe, effective solutions in the field of cardiometabolic therapeutics. We do this by maintaining high ethical and professional standards—and it all starts with people. By empowering our employees to live this mission, we can create a healthier vision for the future.
Our Mission Is To:
Develop and commercialize safe, effective and high-quality pharmaceutical products at a reasonable cost
Be customer focused and provide the highest level of customer support and service
Conduct all business with honesty, professionalism and integrity
Maximize human capital by hiring, training and retaining the very best employees
Aggressively seek new marketing opportunities and maximize the potential of current products